Novartis
Summary
The QA Batch Release Specialist is responsible for the quality assurance release of radioligand therapy drugs manufactured, packaged and tested in compliance to current GMP regulations, procedures and quality systems.
Location Indianapolis, IN
Shift 2nd shift (14:30 - 23:00) Friday – Tuesday
Relocation Support Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you.
Key Responsibilities
Perform release of all manufactured, packaged and tested materials including raw materials, intermediates and drug products. Confirm documentation fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
Controlled issuance of batch records in preparation for manufacturing.
Perform review of manufacturing batch records in preparation for batch release and immediately escalate any discrepancies.
Assist functional areas with timely and compliant final product disposition.
Ensure specifications are in place and within GMP compliance.
Support metric tracking of documentation and release data for continuous improvement.
Serve as a valued business partner with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
Manage CAPA and improve processes within QA Batch release.
Organize and file executed and associated GMP documentation (e.g., batch records).
Maintain batch documentation library (record check-in, check-out, follow-up, distribution).
Essential Requirements
Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered.
2+ years of experience in GxP Biopharmaceutical manufacturing operations.
1+ years of experience in a quality assurance role.
Cross-functional collaboration.
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones is desired.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
Novartis Compensation and Benefit Summary The salary for this position is expected to range between $81,200 and $143,000/year. The final salary offered is determined based on factors such as relevant skills and experience, and will be reviewed periodically upon joining Novartis. Novartis may change the published salary range based on company and market factors. Compensation includes a performance-based cash incentive and, depending on the level, eligibility for annual equity awards.
US-based eligible employees receive a comprehensive benefits package that includes health, life, and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Employees also receive a generous time off package including vacation, personal days, holidays, and other leaves.
Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to hrrecruiting@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
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Location Indianapolis, IN
Shift 2nd shift (14:30 - 23:00) Friday – Tuesday
Relocation Support Novartis is unable to offer relocation support for this role. Please only apply if the location is accessible for you.
Key Responsibilities
Perform release of all manufactured, packaged and tested materials including raw materials, intermediates and drug products. Confirm documentation fully adheres to cGMP, including data integrity. Ensure timely escalation to management of all applicable incidents.
Controlled issuance of batch records in preparation for manufacturing.
Perform review of manufacturing batch records in preparation for batch release and immediately escalate any discrepancies.
Assist functional areas with timely and compliant final product disposition.
Ensure specifications are in place and within GMP compliance.
Support metric tracking of documentation and release data for continuous improvement.
Serve as a valued business partner with a culture of safety, quality, delivery to patients, cost, compliance, and data integrity.
Manage CAPA and improve processes within QA Batch release.
Organize and file executed and associated GMP documentation (e.g., batch records).
Maintain batch documentation library (record check-in, check-out, follow-up, distribution).
Essential Requirements
Bachelor's Degree, preferably in Life Sciences, chemistry, or related relevant degree. In lieu of degree, 5 years in a role within pharma industry that includes quality assurance and batch release experience will be considered.
2+ years of experience in GxP Biopharmaceutical manufacturing operations.
1+ years of experience in a quality assurance role.
Cross-functional collaboration.
QA and QC experience in biotech pharmaceutical industry with environmental monitoring & cleanliness zones is desired.
Proven track record and practical experience with cGMP requirements.
Knowledge of FDA and EU regulations and experience in US and international regulatory agency inspections.
Novartis Compensation and Benefit Summary The salary for this position is expected to range between $81,200 and $143,000/year. The final salary offered is determined based on factors such as relevant skills and experience, and will be reviewed periodically upon joining Novartis. Novartis may change the published salary range based on company and market factors. Compensation includes a performance-based cash incentive and, depending on the level, eligibility for annual equity awards.
US-based eligible employees receive a comprehensive benefits package that includes health, life, and disability benefits, a 401(k) with company contribution and match, and a variety of other benefits. Employees also receive a generous time off package including vacation, personal days, holidays, and other leaves.
Why Novartis Helping people with disease and their families takes more than innovative science. It takes a community of smart, passionate people like you. Collaborating, supporting, and inspiring each other. Combining to achieve breakthroughs that change patients’ lives. Ready to create a brighter future together?
https://www.novartis.com/about/strategy/people-and-culture
Join our Novartis Network Not the right Novartis role for you? Sign up to our talent community to stay connected and learn about suitable career opportunities as soon as they come up: https://talentnetwork.novartis.com/network
Benefits and Rewards Read our handbook to learn about all the ways we’ll help you thrive personally and professionally: https://www.novartis.com/careers/benefits-rewards
EEO Statement The Novartis Group of Companies are Equal Opportunity Employers. We do not discriminate in recruitment, hiring, training, promotion or other employment practices for reasons of race, color, religion, sex, national origin, age, sexual orientation, gender identity or expression, marital or veteran status, disability, or any other legally protected status.
Accessibility & Reasonable Accommodations The Novartis Group of Companies are committed to working with and providing reasonable accommodation to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application process, or to perform the essential functions of a position, please send an e-mail to hrrecruiting@novartis.com or call +1(877)395-2339 and let us know the nature of your request and your contact information. Please include the job requisition number in your message.
Seniority level Mid-Senior level
Employment type Full-time
Job function Quality Assurance
Industries Pharmaceutical Manufacturing
#J-18808-Ljbffr